MDCG issues guidance on In Vitro Diagnostic Classification Rules

The European Commission’s Medical Device Coordination Group (MDCG) has published long-awaited guidance, MDCG 2020-16, that explains how to classify products for compliance with the EU’s In Vitro Diagnostics Regulation (IVDR, 2017/746).

The IVDR is replacing the classification system from the In Vitro Diagnostics Directive (IVDD, 98/79/EC) with a risk-based system, which will require the reclassification of many IVDs into higher classes, thus requiring the involvement of a Notified Body for the first time. The new regulation goes into effect on May 26, 2022, except for in vitro diagnostics that qualify for a grace implementation period that extends to May 27, 2024.

The new guidance offers numerous examples to help manufacturers understand how their IVDs should be classified for compliance with the regulation.